Prescription Drugs

U.S. Food and Drug Administration will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to amend the Biologics License Application for PROVENGE (sipuleucel-T).

Nuvion, an antibody in development as a treatment for intravenous steroid-refractory ulcerative colitis, administered on day 1 and day 2, produced a sustained clinical response up to 310 days and was adequately tolerated.

KV Pharmaceutical Company has received final approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application to market its 100 mg and 200 mg strengths of metoprolol succinate extended-release tablets.

Abbott will present new data from its SPIRIT family of clinical trials studying the XIENCE V Everolimus Eluting Coronary Stent System, and the ABSORB trial of the world's first fully bioabsorbable drug-eluting coronary stent.

"A Dialogue: Seeking Common Ground On Drug Safety" launches a new series of forums to address policy issues related to the anticipated passage and implementation of the Food & Drug Administration Revitalization Act.

Medicare proposed decision to limit coverage of erythropoiesis stimulating agent (ESA) treatment for beneficiaries with certain cancers and related neoplastic conditions, either because of a deleterious effect of the ESA on the beneficiaries' underlying disease or because the underlying disease increases their risk of adverse effects related to ESA use.

Health Canada is warning patients taking the anti-epilepsy medications Depakene 500 mg and ratio-VALPROIC 500 mg that they may not be getting the full dose of the active drug, which could result in inadequate treatment of their seizures.

Barr Pharmaceuticals announced that its subsidiary has received tentative approval from the U.S. Food and Drug Administration for its generic version of Janssen Pharmaceutica Products, L.P.'s Razadyne (Galantamine Hydrobromide), 4mg, 8mg and 12mg Tablets.

The United States Senate overwhelmingly passed significant prescription drug safety reforms to give FDA more power to deal with unsafe medicines on the market. Being the first significant drug safety measure in 45 years, the House is urged to pass a strong prescription drug safety bill.